Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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058
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Date of Entry 05/30/2022
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FR Recognition Number
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10-131
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Standard | |
ISO 15798 Fourth edition 2022-01 Ophthalmic implants - Ophthalmic viscosurgical devices |
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Scope/AbstractThis document is applicable to ophthalmic viscosurgical devices (OVDs), a class of surgical invasive medical devices with viscous and/or viscoelastic properties, intended for use during surgery in the anterior segment of the human eye. OVDs are designed to create and maintain space, to protect intraocular tissues and to manipulate tissues during surgery.
This document specifies requirements with regard to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling and information supplied by the manufacturer of these devices. |
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Extent of Recognition
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Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§886.4275 |
Aid, Surgical, Viscoelastic
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Class 3
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LZP
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Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and Food and Drug Administration Staff: Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices, Issued August 2015.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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FDA Technical Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |